Regulatory Officer
Job Description
Join our team of experts in regulatory and ethics submissions of clinical studies. You will focus on facilitating the start of research projects of novel medicinal products, while taking a step further in your professional career.
Hybrid working arrangement in Milan area
Your role:
- Support country-level regulatory activities for Italy under the EU Clinical Trials Regulation (CTR)
- Prepare and coordinate CTR Part II submission packages for Italy
- Communicate with regulatory authorities, project teams and vendors on regulatory-related matters
- Review translations of essential documents subject to clinical trial submission
- Track the regulatory project documentation flow
- Review documents to greenlight IP release to sites
Join our team of experts in regulatory and ethics submissions of clinical studies. You will focus on facilitating the start of research projects of novel medicinal products, while taking a step further in your professional career.
Hybrid working arrangement in Milan area
Your role:
- Support country-level regulatory activities for Italy under the EU Clinical Trials Regulation (CTR)
- Prepare and coordinate CTR Part II submission packages for Italy
- Communicate with regulatory authorities, project teams and vendors on regulatory-related matters
- Review translations of essential documents subject to clinical trial submission
- Track the regulatory project documentation flow
- Review documents to greenlight IP release to sites